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P282 The long-term effect of biologics in newborns

B. Truta*, J. Canner, J. Efron, B. Safar

Johns Hopkins University, Baltimore, United States

Background

Pregnant women with autoimmune diseases frequently require maintenance therapy with anti-tumour necrosis factor (Anti-TNFs) drugs during pregnancy. It has been demonstrated that these drugs are actively transported across placenta reaching high levels in the blood of newborns; the long-term effect of intrauterine exposure to anti-TNFs is unknown.

Aim: to assess the effect of intrauterine exposure to biologics in infants.

Methods

This was a retrospective study of all deliveries registered with the Truven Health Analytics MarketScan database from January 2010 to December 2012. All the women with autoimmune diseases (inflammatory bowel disease, rheumatoid arthritis, psoriasis, lupus erythematous syndrome, etc) requiring anti-TNFs therapy during pregnancy were identified and linked to their children included in the database. Study patients were all of the infants from the women treated with anti-TNFs during pregnancy. The information regarding delay in achieving developmental milestones and abnormalities in the physical, cognitive, social, emotional, and language development were identified using ICD-9 codes. Statistical analysis was performed using Chi-square test, which was also used to compare developmental delays or abnormalities registered in infants with and without intrauterine exposure to anti-TNFs.

Results

There were 193 study patients and 390 controls: 39% were exposed to infliximab, 47% were exposed to adalimumab, and 14% were exposed to certolizumab. The newborns were followed-up for a median of 381 days, with a range of 0–720 days. Mean age at delivery was similar in exposed and non-exposed women: 31+/-5.49 vs 30+/-6.68, p = NS. There was no significant difference in the number of cases identified with developmental delay/abnormalities within the 2 groups: 5 (2.5%) vs 10.879 (2.7%), p = NS; infants of both groups had similar physical, cognitive, social, emotional and development; moreover, there were no cases of mental retardation, autism, hyperkinetic syndrome (ADHD), or language and speech disorder associated with anti-TNFs use in pregnancy. The infant’s weight and height was not significantly affected by the intrauterine exposure to anti-TNFs.

Conclusion

The use of anti-TNFs therapy in pregnancy is not associated with the developmental delays or abnormalities in infants.